Safety and immunogenicity of COVID-19 vaccines for SARS-CoV-2 in lung cancer patients

Completed

• Conditions: COVID vaccine in lung cancer; COVID-19 Vaccines; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Lung Neoplasms

• Registration Number: TCTR20240811003
• Lead Sponsor: Faculty of Medicine, Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-10-07
• Study Start: 2024-08-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

1. age 18 years or above
2. Has an appointment to receive COVID-19 vaccine
3. Confirmed diagnosis of lung cancer by pathology or cytology
4. Life expectancy is more than 6 months at the time receiving first

Exclusion Criteria

1. Previously diagnosed COVID-19 in the past 90 days
2. High-risk epidemiology history within 14 days before enrolment e.g. close contact with index cases or visiting/ living in outbreak area
3. Receive only one dose of COVID-19 vaccine
4. Receive blood products, blood components, or immunoglobulin within the past 90 days
5. Receive live attenuated vaccine in the past 28 days
6. Receive inactivated or subunit vaccines in the past 14 days
7. Women in lactation, pregnancy, or planned pregnancy during the study period
8. Known allergy to any vaccine component
9. Has signs and symptoms of active skin infection at injection site
10.Known history of HIV infection
11. Has uncontrolled medical illness that include cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological disease

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Seroconversion rate of neutralizing antibody 28 days after second dose of vaccine percent inhibition of neutralizing antibody

Secondary Outcome Measures

Name	Time	Method
Seroconversion rate of neutralizing antibody 6 months after second dose of vaccine percent inhibition of neutralizing antibody,Cell mediated immunity 28 days after second dose of vaccine intracellular cytokine staining for IFN-gamma, TNF-alpha, IL-4, IL-10 in CD3,CD4 and CD8 positive cell,safety outcome 28 days and 6 months after second dose of vaccine patients reported outcome using questionnaire interview about adverse events